NOT AT ALL
"In light of the advent news, Dr ashkan’s 2 month estimate, and GZ’s email to Lefty49 on IHUB, I still believe the MAA will be approved this year."
Most logical bullish interpretation:NWBO may have amended the MAA to include Flaskworks as the manufacturing method. That would explain both the long delay and why the application was not part of the backlog the MHRA said it cleared by 3/31/25.It also explains why NWBO has not submitted anything to NICE yet, because you would not do that until manufacturing is finalized.This fits with GZ’s 11/2025 email to Lefty49 saying there was very little MHRA interaction before the backlog was cleared.I never like calling delays good news, but this explanation does fit the facts better than most.
Most logical bearish interpretation:The MAA might have been one of the applications flagged with “major issues” and sent to CHM. That would explain the delay and why it was not in the cleared backlog. It also lines up with GZ’s comment about minimal MHRA communication.Should NWBO have disclosed something like that, probably. But if they believed the issues were fixable, they might have decided not to announce it.Even with this interpretation, the Advent deal timing and GZ’s emails suggest the issues were ultimately resolved, and approval still seems more likely than not, although it might still take some time.
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